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Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332414Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 84332414 ADAPTIX 24MM X 14MM · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000202934), received between Sep 8, 2021 and Sep 13, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Migration2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 13, 2021Migration; Migration

    THE INFORMATION WAS REPORTED BY HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGRADING A PATIENT WITH DEGENERATIVE DISK DISEASE FOR L4-S1 MAST TLIF SPINAL THERAPY. IT WAS REPORTED THAT DURING POST OP VISIT TO THE CLINIC, ADDITIONAL SCANS WERE TAKEN AND DISCOVERED THE CAGE MIGRATED POSTERIOR. CAGE IS MIGRATING BEFORE THE FUSION WAS COMPLETE. ADDITIONAL SURGERY WAS REQUIRED FOR REMOVAL OF THE CAGE. THERE WAS NO FURTHER INFORMATION REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12458221 ↗
  • InjurySep 8, 2021Migration; Migration

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF AT L5-S1 FOR SPINAL THERAPY WITH DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT ABOUT A MONTH POST OP, THE CAGE HAS MIGRATED POSTERIORLY COMPARED TO TIME OF SURGERY. NO ISSUES PRESENT AT THE TIME OF SURGERY. SURGEON PLAN ON BRINGING IN THE PATIENT TO REMOVE THE CAGE. SURGERY DATE IS UNKNOWN AT THE MOMENT. PATIENT EXPRESSED DISCOMFORT DURING POST-OP CHECKUP. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. INFORMATION STATES THAT ON (B)(6) THE PATIENT CAME BACK IN TO HAVE HIS L5-S1 CAGE REMOVED. DURING THE REVISION CASE, 8 OF THE 10 SCREWS THAT WERE PREVIOUSLY PLACED HAD TO BE REMOVED AND UPSIZED DUE TO THEM BEING LOOSE. THE ONLY SCREWS THAT DIDN'T GET UPSIZED WAS AT THE L4 LEVEL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12437441 ↗

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Sources and updates

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